Full Time
credit manager
working capital
credit analysis
term loan
QA QMS LEAD
Full Time | Bavla | India
Industry : Manufacturing
Role Overview
Designation / RoleAssistant Manager
QualificationB. Pharma, (Preferred – M. Pharma)
Experience10-13 Years
Key Responsibilities
- To review and approve all appropriate quality-related documents.
- To release or reject Finished product.
- Reviewing completed batch production and laboratory control records of critical process steps before release of the Finished products for distribution.
- All deviations, non-conformances shall be investigated and resolved.
- Review and approval of master documents.
- To approve all procedures impacting the quality of intermediates.
- To ensure the self-inspection and /or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
- To ensure evaluation and Approval/ Evaluation /Rejection of change control related to system, facility, product and document and study of impact related to changes.
- Notify concerned Qualified person of the party in case of any changes made /proposed in the product.
- Approval of unit SOPs, document of quality function, validation protocols /report, layouts /plans, Organization charts, documents of quality function.
- Ensure strict adherence to safety, health and environment and SOP.
- Responsible for the decision-making process in all matter that affect the quality of products including development, Production, Laboratory, Storage, Distribution, Vendors and Third-Party Contractors.
- Ensure that finished drug products are manufactured in a way that takes account of the requirement of cGMP.
- To perform product quality reviews for any abnormal observations and trend of data and investigation of the same as applicable.
- To ensure that qualification and maintenance of department, premises and equipment are in place.
- To ensure that the required initial and continuing training of department personnel is carried out as per the SOP timeline.
- Responsible for approval / Rejection of Deviation, CAPA and Complaint.
- Ensure Investigation of Out of Specification, Out of Trend, Rejection, Batch Failures, Process and Procedure Deviation are appropriately performed and documented.
- Keeps informed of existing and proposed FDA regulation relating to assigned responsibility, appraised their effect on company operations and sees that appropriate action is taken to assure compliance with FDA Regulator and compliance for various regulatory agencies.
- To ensure and monitor compliance cGMP as per requirements of the respective authority.
- To propose the quality system and quality policy.
- Critical examining, monitoring and control on manufacturing environment in view of minimizing product contamination.
- To ensure the manufacturing is carried out as per approved procedure, accepted for registration by concern regulatory agency. Help in providing of documents required for regulatory affairs.
- To assure that all validations are properly planned, executed, and documented.
- Monitor qualification of new /modified areas /equipment and also ensure their re- qualification.
- Ensure review of technical agreement and quality agreement.
- Be notified of all circumstances which may affect the quality of products, whether before or after release for sale /supply.
- Ensure investigation of recalled /returned products.
- To monitor returned goods, procedures, salvage and approve disposition.
- Ensure investigation of product complaints monitoring and addressing queries related to product quality issued.
- Ensure the review of annual product quality report of all drug products and its relevant data / records to assure that products are meeting consistently quality standards.
- Control and monitor Technology Transfer Activities.
- To assure that appropriate calibration and preventive maintenance of manufacturing equipment are conducted as scheduled and record thereof is maintained.
- Attend to all customer /regulation audits and compliance and response to audit observation.
- To participate in Quality management review.
- Ensure storage, retention and destruction of documents and records as per SOP.
- Responsible for compilation of site master file.
- Manage Pharma Cloud system related activities and also ensure timely and accurate batch release in Pharma Cloud.
- Any Other job responsibility given by the management
Skill Set
Quality-related document review
Finished product release
Batch production record review
Laboratory control records review
Deviation investigation
Non-conformance resolution
Master document review and approval
Quality procedure approval
Self-inspection
Quality audit
Change control evaluation
Product change impact study
Unit SOP approval
Validation protocols and report approval
Safety adherence
Health and environment adherence
Decision-making in product quality
cGMP compliance
Product quality reviews
Abnormal observation investigation
Qualification and maintenance of department and equipment
Training execution
Deviation approval
CAPA approval
Complaint approval
Out of specification investigation
Out of trend investigation
Batch failure investigation
Process deviation documentation
FDA regulation compliance
Regulatory agency compliance
Quality system proposal
Quality policy proposal
Manufacturing environment contamination control
Manufacturing procedure compliance
Regulatory affairs documentation support
Validation planning and documentation
Area and equipment qualification and re-qualification
Technical agreement review
Quality agreement review
Product quality impact notification
Recalled product investigation
Returned goods monitoring
Product complaint investigation
Annual product quality report review
Technology transfer control
Equipment calibration and preventive maintenance
Customer audit participation
Regulatory audit participation
Quality management review participation
Document retention and destruction
Site master file compilation
Pharma Cloud system management
Batch release management
Application
